18. How Does the IRB Decide to Approve Human Research?

All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. The criteria are based on the principles of justice, beneficence and autonomy as discussed in the Belmont Report and are specified below. In addition, certain other criteria that are unique to Maine Medical Center may apply and must be met as well. (IRB SOP RR 402)

MMC IRB Minimal Criteria for Approval of Research;

In order for a research project to be approved, the IRB must find that:

1. Risks to subjects are minimized:

By using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and

Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.

In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

2. Selection of subjects is equitable.

In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.

3. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with and to the extent required by appropriate local, state and federal regulations.

4. Informed consent will be appropriately documented as required by local, state and federal regulations.

5. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

6. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

7. When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence or for subjects found at international sites, additional safeguards have been included in the study and in the IRB review process, to protect the rights and welfare of these subjects.

8. Studies are reviewed at periods appropriate to the degree of risk that research subjects are exposed to due to their participation in the study, but at least annually. In assessing the appropriate period of review, the Board must be cognizant and take into account issues such as whether the research involves a new innovative therapy, a vulnerable population or certain ethical or economic issues.